|Akorn up on stong earnings forecast. After the bell: Cadence gets FDA nod|
|By BioMedReports.com Staff|
|Tuesday, 02 November 2010 18:34|
After the bell today Cadence Pharmaceuticals, Inc. (Nasdaq:CADX) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
"The approval of OFIRMEV is a significant milestone for Cadence as we advance our mission to improve the lives of hospitalized adults and children," said Ted Schroeder, President and CEO of Cadence. "IV acetaminophen is the unit market share leader among all injectable pain medications in Europe. With our planned launch early in the first quarter of 2011, we believe that OFIRMEV will fill a significant gap in the United States for the treatment of pain and fever in the hospital setting."
Shares of Cadence initially were trading down in extended trading, falling as low as $8.00 per share before recovering and ending at $8.90, down 7 cents from Tuesdays close of $8.97.
Shares of Akorn, Inc. (NASDAQ:AKRX) rose more than 14% in heavy trading Tuesday. After the bell Monday the company reported improved Q3 results and upped its 2010 FY outlook. The cpmpany said it noe expects revenues of $84-85 million, up from its previous forecats of $71-75 million.
Shares of Akorn surged 64 cents or 14.41% to $5.08.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it has been awarded a total of $488,958 in grants under the qualifying therapeutic discovery project program established under Section 48D of the Internal Revenue Code. The Company submitted applications for its ANX-530, or Exelbine, and ANX-514 projects and a grant in the amount of $244,479 has been approved for each project.
ArQule, Inc. (Nasdaq:ARQL) today announced that it has been awarded grants totaling approximately $978,000 under the Patient Protection and Affordable Care Act of 2010.
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that it has been awarded $977,917 in grants under the Therapeutic Discovery Tax Credit program that was enacted under the U.S. government's Patient Protection and Affordable Care Act.
CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, today announced that it has been awarded a nontaxable grant of approximately $735,000 related to its INNO-206, tamibarotene and bafetinib programs under the Qualifying Therapeutic Discovery Project Program included in the Patient Protection and Affordable Care Act, H.R. 3590, signed into law in March 2010. The grant is being allocated in two tranches, with $635,000 to be received in 2010 and $100,000 in 2011.
DARA BioSciences (Nasdaq:DARA) announced today grant approvals by the Internal Revenue Service under the Patient Protection and Affordable Care Act of 2010 for KRN5500 and DB959 in the amount of approximately $500,000 for the calendar year 2009.
Geron Corporation (Nasdaq:GERN) today announced that the company has been awarded $1.2 million in grants under the Qualifying Therapeutic Discovery Project (QTDP) program.
Icagen, Inc. (Nasdaq:ICGN) today announced that it has been awarded approximately $733,000 of federal government grants under the qualifying therapeutic discovery project program under section 48D of the Internal Revenue Code.
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that all 12 applications from the Company were certified by the Internal Revenue Service of the Department of Treasury as qualified investments in accordance with the Qualifying Therapeutic Discovery Project (QTDP) program under section 48D of the Internal Revenue Code. As a result, the Company will receive an aggregate cash award of $2.9 million.
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced its partner GlaxoSmithKline (NYSE:GSK) was granted approval from the Japanese Ministry of Health, Labour and Welfare for Revolade® (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag is indicated for adult chronic ITP splenectomized patients who have not responded (are refractory) to other treatments, such as corticosteroids and immunoglobulins. Eltrombopag may also be considered as second-line treatment for adult non-splenectomized patients where surgery is contraindicated.
Separately, Ligand Pharmaceuticals today announced it has been awarded $1,955,834 in immediately available funds from the U.S. government under HR: 3590 – Patient Protection and Affordable Care Act. The award comprises separate payments of approximately $245,000 for each of eight drug development programs at Ligand.
Neuralstem, Inc. (NYSE Amex: CUR) announced that it has been awarded three Federal grants, totaling $733,438 through the Patient Protection and Affordable Care Act, which supports investments in qualifying therapeutic discovery projects.
Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that it has been awarded over $2,000,000 in research grants by the U.S. government. These grants are planned to support the Company's on-going biomedical research for nervous system disorders and oncology. Pain Therapeutics expects to receive funding from these research grants now through the end of 2011.
Palatin Technologies, Inc. (NYSE Amex: PTN), announced today that it has received $978,000 in grants under the Patient Protection and Affordable Care Act of 2010 (PPACA), with $847,000 available immediately and $131,000 available no later than 30 days after Palatin's fiscal year ending June 30, 2011.
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced the award of $977,917 under the Internal Revenue Service's Section 48D for Qualifying Therapeutic Discovery Projects.
Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) announced today it has entered into an exclusive 5-year Laboratory Services Agreement (LSA) with Provista Diagnostics Inc. (Provista). Provista conducts diagnostic research and provides CLIA laboratory developed tests and services to the general public.
Under the terms of the LSA, Provista will have the exclusive rights in the U.S. to develop and market CLIA laboratory developed tests (LDTs) for cancer screening purposes using RPC's proprietary polyclonal antibodies for fibrin and fibrinogen degradation products (FDP).
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) today announced the results of its first non-clinical dry eye study using RGN-259, RegeneRx’s ophthalmic, preservative-free eye drop for the treatment of Dry Eye Syndrome (DES). In the study, animals were treated with RGN-259, a vehicle control and a positive control, doxycycline. Corneal fluorescein staining was used to measure the surface defects after induction of DES using an industry accepted dry eye model. In animals treated with RGN-259, a "dramatic" and statistically significant reduction in corneal staining was observed compared to those treated with the vehicle control and equivalent to original levels seen prior to induction of DES. The treatment effect using RGN-259 was also more pronounced than that observed with the positive control, an accepted treatment for dry eye and ocular surface inflammation.
StemCells, Inc. (Nasdaq:STEM) announced today that it has been awarded cash grants by the U.S. government totaling $977,917 for projects related to the Company's development of cell-based therapeutics targeting the central nervous system (CNS) and the liver.
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced today that it has been awarded $733,000 in funding under the U.S. Government’s Qualifying Therapeutic Discovery Project (QTDP) program.
Also Tuesday:Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board:ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that it has entered into a Cooperative Research and Development Agreement ("CRADA") with The Walter Reed Army Institute of Research.
Alliance Network Communications Holdings, Inc. (PINKSHEETS: ALHN), announced that its Board of Directors has approved the change in the name of the corporation to BioCube Holdings, Inc., to reflect its new principal focus after the previously announced acquisition of BioCube, Inc.
American Physicians Service Group, Inc. ("APS") (NASDAQ:AMPH) today announced results for the quarter and nine months ended September 30, 2010.
Aoxing Pharmaceutical Co., Inc. (NYSE Amex:AXN) ("Aoxing Pharma"), a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, today announced that Hui (David) Shao has resigned from his position as Chief Financial Officer to pursue other opportunities, effective on November 1, 2010.
Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that it has been awarded a $733,438 grant from the Department of Health and Human Services (HHS) under the recently enacted Patient Protection and Affordable Care Act.
Assisted Living Concepts, Inc. ("ALC") (NYSE: ALC) reported net income of $4.6 million ($0.39 per diluted common share) in the third quarter of 2010 as compared to net income from continuing operations and net income of $4.2 million ($0.36 per diluted common share) and $3.4 million ($0.29 per diluted common share), respectively, in the third quarter of 2009.
Biodel Inc. (Nasdaq:BIOD) announced today that it has been awarded $1.2 million in research grants under the Internal Revenue Service's therapeutic discovery tax credit program.
BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser company, is pleased to announce the appointment of business and finance veteran Gregory E. Lichtwardt to its Board of Directors, effective immediately.Lichtwardt will also serve on the audit committee of the Board.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, announced financial results today for the third quarter endedSeptember 30, 2010.
Chembio Diagnostics, Inc. (OTCBB: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, reported that it received awards in the total amount of $1.467 million relating to six "Qualifying Therapeutic Discovery Projects" created by Congress on May 21, 2010 under Section 48D of the Internal Revenue Code, as enacted under the Patient Protection and Affordable CareAct of 2010, the major United States federal health care reform legislation enacted earlier this year.
CytoSorbents Corporation (OTCBB:CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, announced the award of a cash grant of up to $488,958 from the Federal Qualifying Therapeutic Discovery Project (QTDP) Program for two products in its pipeline, including the development of CytoSorb™ for the treatment of sepsis and other critical care illnesses.
Depomed, Inc. (NASDAQ: DEPO) announced today that it has been awarded two cash grants totaling approximately $489,000 under the U.S. Government's Qualifying Therapeutic Discovery Project ("QTDP") program.
DURECT Corporation (Nasdaq:DRRX) announced today that it has been awarded grants totaling $733,438 to advance our programs in post-operative pain relief, attention deficit disorder (ADHD) and chronic diseases treated with biologic agents.
Healthnostics, Inc. (PINKSHEETS:HNSS) is seeking blocks of Healthnostics stock of at least 500,000 or more free-trading shares.
IDenta Corp. (PINKSHEETS: IDTA) CEO Yaacov Shoham announced today that the company is in the testing stage of a new type of detection kit that will detect and identify invisible traces of suspected substances that are measured in Nanograms.
Imaging3™, Inc. (OTCBB: IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, announced that the conference call that occurred on November 1, 2010 at 2:30pm PDT is now available to review/listen as a recording on the Imaging3 website.
Kensey Nash Corporation (Nasdaq:KNSY) is scheduled to present at two investor conferences in November.
Marijuana, Inc. (PINKSHEETS: PCIO) is proud to announce their support of California Proposition 19 which will legalize the cultivation of industrial hemp paving the way for the improvement to the economy by bringing new jobs in the manufacturing industry using hemp as the raw material.
Mediware Information Systems, Inc. (NASDAQ: MEDW), a provider of comprehensive healthcare software solutions for blood, medication and performance management, reported total revenue for the first quarter of the 2011 fiscal year of $12.5M, a 17 percent increase from the $10.7M reported in the comparable quarter in fiscal 2010.
Micro Identification Technologies, Inc. (OTCBB:MMTC) (MIT) reported that on October 27, 2010 it conducted a well attended Webinar focusing on the technology and operation of the MIT 1000 Rapid Microbial Identification System.
Robert H. Lorsch, Chairman and Chief Executive Officer of MMRGlobal, Inc. (OTCBB: MMRF), a leading provider of Personal Health Records (PHRs) and electronic document imaging and management systems for healthcare professionals, will address the pressing questions facing physicians and administrators in the healthcare field as Conference Chair of the 7th Annual Fall Health IT Summit on opening day November 3, 2010.
MultiCell Technologies, Inc. (OTC Bulletin Board:MCET.OB) announces it has received cash grant awards under the U.S. government's Qualifying Therapeutic Discovery Project ("QTDP") program.
NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced dosing of the first patient in its Phase 2 clinical study of NGX-1998, a liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN).
Pegasystems Inc. (NASDAQ: PEGA), the leader in business process management (BPM) and a leading provider of customer relationship management (CRM) solutions, today releasedits new Adverse Event Case Processing solution for the Life Sciences market.
Pharmacyclics, Inc. (Nasdaq:PCYC), a biopharmaceutical company focused on developing and commercializing innovative small molecule drugs for the treatment of cancer and mediated diseases, today announced that senior management will host a conference call and live audio webcast on Monday, November 8th, at 5:00 pm ET to discuss the company's first quarter fiscal 2011 financial and operational results.
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today reported financial results for the third quarter ended September 30, 2010.
Palatin Technologies, Inc. (NYSE Amex:PTN), announced today that it has received $978,000 in grants under the Patient Protection and Affordable Care Act of 2010 (PPACA), with $847,000 available immediately and $131,000 available no later than 30 days after Palatin's fiscal year ending June 30, 2011.
QIAGEN N.V. (Nasdaq:QGEN) today announced the Webcast of its third quarter 2010 financial results call. The Webcast will take place at 9:30 a.m. EST on Tuesday, November 9, and will include remarks by Peer M. Schatz, President and Chief Executive Officer, and Roland Sackers, Chief Financial Officer.
Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today it has entered into an exclusive 5-year Laboratory Services Agreement (LSA) with Provista Diagnostics Inc. (Provista).
Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) will webcast its presentation at the 2010 Credit Suisse Annual Healthcare Conference on Wednesday, November 10, 2010.
Regenicin, Inc. (OTC Bulletin Board:WDST), a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs, will participate in an event to celebrate the newest advancements in regenerative medicine on November 9th, 2010 in Walkersville, MD.
Repligen Corporation (Nasdaq:RGEN) today reported results for the second quarter of fiscal year 2011, ended September 30, 2010.
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) announced today that it has been awarded $244,000 under the IRS Qualifying Therapeutic Discovery Project (QTDP) program, which was created by Congress as part of the Patient Protection and Affordable Care Act of 2010.
Talecris Biotherapeutics (Nasdaq:TLCR) announced today the Canadian launch of PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human])(A1PI), a more concentrated and purified formulation of PROLASTIN®, the only approved alpha1-augmentation therapy in Canada for more than 20 years.
UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce the recent signing of agreements with 3 new distributors to commence offering the ViraTech UV-400 to their market segment commercial accounts.
Verenium Corporation (Nasdaq:VRNM), a pioneer in the development and commercialization of high-performance industrial enzyme solutions, today announced that it will release 2010 third quarter financial results on Tuesday, November 9, 2010 after market close.
David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB:VCRT), today announced that the Company is actively recruiting new independent sales representatives across the United States to drive sales of its PD2i Analyzer™.
Virtual Medical Centre Inc. ("VMC" or "the Company") (OTCBB:VMCT) is pleased to announce the creation of its Executive Advisory Committee (EAC).